BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2170032 · Received July 15, 2011

    Report

    Report Number
    9612164-2011-00748
    Event Type
    Death
    Date Received
    July 15, 2011
    Date of Event
    April 29, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (DEATH).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE LEFT MAIN DURING INDEX PROCEDURE. PTS CURRENT CARDIAC STATUS WAS UNSTABLE ANGINA AT 30 DAY, 6 MONTH, 1 YEAR AND 1.5 YEAR FOLLOW UPS. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 2 YEAR AND 2.5 YEAR FOLLOW UPS. IT IS REPORTED THAT THE PT EXPIRED APPROX 33.5 MONTHS POST INDEX PROCEDURE. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death